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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00426660




Registration number
NCT00426660
Ethics application status
Date submitted
22/01/2007
Date registered
25/01/2007
Date last updated
29/06/2016

Titles & IDs
Public title
Expanded Access Program for Maraviroc At Multiple Centers
Scientific title
A Multicenter, Open Label, Expanded Access Trial Of Maraviroc
Secondary ID [1] 0 0
2006-004306-50
Secondary ID [2] 0 0
A4001050
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - maraviroc

Experimental: 1 -


Treatment: Drugs: maraviroc
The nominal dose for maraviroc is 300 mg twice a day (BID). However, the dosage of maraviroc should be adjusted based on optimal background therapy (OBT) patient is taking. If OBT includes CYP3A4 inhibitor (with or without inducers) maraviroc dose should be 150 mg BID and if OBT includes CYP3A4 inducer (without inhibitors) maraviroc dose should be 600mg BID. If OBT does not include any CYP3A4 inducers or inhibitors maraviroc dose should be 300 mg BID.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Grade 3 and Grade 4 Adverse Events (AE)
Timepoint [1] 0 0
Baseline up to Week 144
Primary outcome [2] 0 0
Percentage of Participants With Grade 3 Laboratory Abnormalities Without Regards to Baseline Abnormalities
Timepoint [2] 0 0
Baseline up to Week 144
Primary outcome [3] 0 0
Percentage of Participants With Grade 4 Laboratory Abnormalities Without Regards to Baseline Abnormalities
Timepoint [3] 0 0
Baseline up to Week 144
Primary outcome [4] 0 0
Percentage of Participants With Acquired Immunodeficiency Syndrome (AIDS)-Defining Illnesses
Timepoint [4] 0 0
Baseline up to Week 144
Primary outcome [5] 0 0
Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Baseline Viral Load
Timepoint [5] 0 0
Baseline up to Week 144
Primary outcome [6] 0 0
Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Baseline/Nadir CD4 Cell Counts
Timepoint [6] 0 0
Baseline up to Week 144
Primary outcome [7] 0 0
Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Time on Therapy
Timepoint [7] 0 0
Baseline up to Week 144
Primary outcome [8] 0 0
Percentage of Participants With All Causality Treatment-emergent Adverse (AEs) Events by Gender
Timepoint [8] 0 0
Baseline up to Week 144
Primary outcome [9] 0 0
Percentage of Participants With Treatment-emergent Adverse Events (AEs) by Race
Timepoint [9] 0 0
Baseline up to Week 144
Primary outcome [10] 0 0
Percentage of Participants With Treatment-emergent Adverse Events (AEs) by Age
Timepoint [10] 0 0
Baseline up to Week 144
Primary outcome [11] 0 0
Percentage of Participants With Treatment-emergent Averse Events (AEs) by Baseline Hepatitis B and Hepatitis C Virus Serology Status
Timepoint [11] 0 0
Baseline up to Week 144
Secondary outcome [1] 0 0
Percentage of Participants With =0.5 log10 Reduction From Baseline in Human Immunodeficiency Virus 1 Ribonucleic Acid (HIV 1 RNA)
Timepoint [1] 0 0
Baseline up to Week 144
Secondary outcome [2] 0 0
Percentage of Participants With =1.0 log10 Reduction From Baseline in HIV 1 RNA
Timepoint [2] 0 0
Baseline up to Week 144
Secondary outcome [3] 0 0
Percentage of Participants With HIV-1 RNA Levels Below the Limit of Quantification: <400 Copies/mL
Timepoint [3] 0 0
Baseline up to Week 144
Secondary outcome [4] 0 0
Percentage of Participants With HIV-1 RNA Levels Below the Limit of Quantification: <50 Copies/mL
Timepoint [4] 0 0
Baseline up to Week 144
Secondary outcome [5] 0 0
Change From Baseline in CD4 Cell Count
Timepoint [5] 0 0
Baseline up to Week 144
Secondary outcome [6] 0 0
Change From Baseline in CD4 Cell Count Percent
Timepoint [6] 0 0
Baseline up to Week 144
Secondary outcome [7] 0 0
Change From Baseline in CD8 Cell Count
Timepoint [7] 0 0
Baseline up to Week 144
Secondary outcome [8] 0 0
Change From Baseline in CD8 Cell Count Percent
Timepoint [8] 0 0
Baseline up to Week 144
Secondary outcome [9] 0 0
Median Time to Virologic Failure
Timepoint [9] 0 0
Day 1 up to Week 144
Secondary outcome [10] 0 0
Percentage of Participants With Changes in HIV-1 RNA Level in Participants Meeting the Definition of Virologic Failure
Timepoint [10] 0 0
Baseline up to Week 144
Secondary outcome [11] 0 0
Percentage of Participants With Change in Chemokine Co-receptor Tropism From Screening to Time of Virologic Failure
Timepoint [11] 0 0
Screening up to Week 144
Secondary outcome [12] 0 0
Number of Participants With Reduced Maraviroc Susceptibility as Defined by Change From Baseline to Time of Virologic Failure in Inhibitory Concentration of 50% (IC 50) and Presence of Plateau
Timepoint [12] 0 0
Baseline up to Week 144
Secondary outcome [13] 0 0
Number of Participants With Emergence of Resistance to Maraviroc as Defined by Genotypic Changes in the V3 Loop of Glycoprotein 120 (gp 120)
Timepoint [13] 0 0
Baseline up to Week 144

Eligibility
Key inclusion criteria
* Subjects must be failing to achieve adequate virologic suppression on their current regimen and have HIV-1 RNA greater than or equal to 1000 copies/ml, at screening
* Have only R5 HIV-1 at Screening as verified by the Monogram Biosciences Trofile assay
* Minimum age must be 16 years or minimum adult age as determined by local regulatory authorities or directed by local law.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Failed prior treatment with any CCR5 antagonist, in any ongoing CCR5 trial or having previously prematurely discontinued Maraviroc in trials

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2010
Sample size
Target
Accrual to date
Final
1047
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Holdsworth House Medical Practice - Darlinghurst
Recruitment hospital [2] 0 0
St. Vincent's Hospital - Darlinghurst
Recruitment hospital [3] 0 0
Albion Street Centre - Surry Hills
Recruitment hospital [4] 0 0
Westmead Hospital - Wentworthville
Recruitment hospital [5] 0 0
AIDS Medical Centre - Brisbane
Recruitment hospital [6] 0 0
Infectious Diseases Unit - Herston
Recruitment hospital [7] 0 0
Infectious Diseases Unit - Adelaide
Recruitment hospital [8] 0 0
Melbourne Sexual Health Centre - Carlton
Recruitment hospital [9] 0 0
Clinical Research Unit, Infectious Diseases - Melbourne
Recruitment hospital [10] 0 0
Northside Clinic - North Fitzroy
Recruitment hospital [11] 0 0
Prahran Market Clinic - South Yarra
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2010 - Surry Hills
Recruitment postcode(s) [3] 0 0
2145 - Wentworthville
Recruitment postcode(s) [4] 0 0
4000 - Brisbane
Recruitment postcode(s) [5] 0 0
4029 - Herston
Recruitment postcode(s) [6] 0 0
5000 - Adelaide
Recruitment postcode(s) [7] 0 0
3053 - Carlton
Recruitment postcode(s) [8] 0 0
3004 - Melbourne
Recruitment postcode(s) [9] 0 0
3068 - North Fitzroy
Recruitment postcode(s) [10] 0 0
3141 - South Yarra
Recruitment outside Australia
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United States of America
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Alabama
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Romania
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Romania
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Bucharest
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Constanta
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Iasi
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Alicante
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Barcelona
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Bilbao
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Gijon
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Pontevedra
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San Sebastian
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Santa Cruz de Tenerife
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Tarragona
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Malaga
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Sevilla
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Valencia
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Switzerland
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Zürich
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Taiwan
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Kaohsiung County
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United Kingdom
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Sussex
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United Kingdom
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Crumpsall, Manchester
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United Kingdom
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Edinburgh
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United Kingdom
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London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ViiV Healthcare
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To provide access to maraviroc to patients who have limited or no therapeutic treatment options and to collect more safety data in a broader patient population.
Trial website
https://clinicaltrials.gov/study/NCT00426660
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00426660